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FDA 510(k) Application Details - K974203
Device Classification Name
Ocular Peg
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510(K) Number
K974203
Device Name
Ocular Peg
Applicant
INTEGRATED ORBITAL IMPLANTS, INC.
4329 GRAYDON RD.
SAN DIEGO, CA 92130 US
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Contact
FLOYD G LARSON
Other 510(k) Applications for this Contact
Regulation Number
886.3320
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Classification Product Code
MQU
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More FDA Info for this Product Code
Date Received
11/10/1997
Decision Date
02/04/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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